FDA Label for Childrens Allergy Relief
View Indications, Usage & Precautions
Childrens Allergy Relief Product Label
The following document was submitted to the FDA by the labeler of this product Supervalu Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
Active Ingredient (In Each 5 Ml)
Loratadine 5 mg
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Otc - Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Otc - Ask Doctor
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
Otc - When Using
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
Stop Use And Ask A Doctor If
- an allergic reaction to this product occurs. Seek medical help right away.
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
| adults and children 6 years and over | 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours |
| children 2 to under 6 years of age | 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours |
| consumers with liver or kidney disease | ask a doctor |
Other Information
- safety sealed: do not use if imprinted safety seal is torn or missing
- store between 2° and 25°C (36° and 77°F)
Inactive Ingredients
artificial peach flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose
Principal Display Panel - 120Ml Bottle Carton
equaline®
compare to
Claritin®
active ingredient*
original
prescription strength
ages
2 years
and
older
children's
allergy
relief syrup
loratadine oral solution
5 mg/5 mL antihistamine
24 hour
non-drowsy†
allergy relief
relief of:
- sneezing
- runny nose
- itchy, watery eyes
- itchy throat or nose
†When taken as directed.
See Drug Facts Panel.
fruit flavored
syrup
4 FL OZ
(120mL)
* Please review the disclaimer below.